Tuberculosis

Inverness Medical Innovations, Inc. (Amex: IMA), a leading provider of near-patient diagnostics, monitoring and health management solutions, is featuring its new TB diagnostic test, the Clearview TB ELISA, at the International AIDS conference (AIDS 2008).

The test, which was introduced to developing world markets in July 2008, provides a much needed aid in the diagnosis of Mycobacterium tuberculosis (TB) in TB/HIV co-infected patients. By providing reliable information more quickly, when compared to other methods, the Clearview TB ELISA can enable treatment decisions to be made the very same day, allowing for more effective patient health management and mitigating the risk of further transmission to a highly vulnerable population.

The Clearview TB ELISA has shown strong performance in detecting TB in those co-infected with HIV. Clearview TB ELISA uses antibodies specific to the antigen lipoarabinomannan (LAM). Elevated levels of the LAM antigen within the urine of TB/HIV co-infected patients provides a specific and reliable diagnostic target. Clinical data shows that, while microscopy methods detect TB in these TB/HIV co-infected patients, at rates as low as 20%, targeting the LAM antigen using the Clearview TB ELISA can produce detection rates of 80%.

Ron Zwanziger, Inverness' CEO stated, "Introduction of the Clearview TB ELISA is an important first step in making available much-needed diagnostic tools to address the TB epidemic where the need is greatest. We are working hard to build support for its widespread adoption."

There were approximately 33 million people living with HIV infection in 2007 and due to their compromised immune status, more than one third were co-infected with TB. As a result, TB has become a leading cause of death in this population and there is a dire need for reliable TB diagnostics.

By developing new capabilities in near-patient diagnosis, monitoring and health management, Inverness Medical Innovations enables individuals to take charge of improving their health and quality of life. A global leader in rapid point-of-care diagnostics, Inverness' products, as well as its new product development efforts, focus on infectious disease, cardiology, oncology, drugs of abuse and women's health. Inverness is headquartered in Waltham, Massachusetts.

This press release may contain forward-looking statements within the meaning of the federal securities laws, including statements regarding timing of the product release and benefits of the new product. These statements reflect Inverness' current views with respect to future events and are based on its management's current assumptions and information currently available. Actual results may differ materially due to numerous factors including, without limitation, risks associated with market acceptance of the product; Inverness' ability to successfully manufacture and distribute the product; Inverness ability to secure and maintain the regulatory approvals or clearances necessary to sell the product in various markets; and the risks and uncertainties described in Inverness' annual report on Form 10-K, and other factors identified from time to time in its periodic filings with the Securities and Exchange Commission. Inverness undertakes no obligation to update any forward-looking statements contained herein.

Update: 22.07.2008

IMF funding 'fuelling TB deaths'

Strict conditions on international loans have been blamed for thousands of extra tuberculosis deaths in eastern Europe, and former Soviet republics.

Analysts from Cambridge and Yale universities said they had led to less being spent on healthcare.

As a result TB in countries with International Monetary Fund loans rose sharply, they claimed.

A UK TB charity backed the Public Library of Science study findings - but the IMF firmly rejected them.

The resurgence of TB in eastern Europe and the former Soviet Union has caused widespread concern, particularly as it has coincided with an increase in the number of drug-resistant cases.

The IMF is an international organisation which aims to oversee the global financial system, and reduce instability by offering financial packages to governments.

In recent years, it has offered assistance to 21 countries in the region, in the form of loans offered in exchange for the meeting of strict economic targets.

The researchers claimed it was efforts to meet these targets that was undermining the fight against TB by drawing funding away from public health.

They looked at the timing of rises in the TB rate, and compared them with the timing of IMF intervention.

'Related rises'

They claimed a direct relationship could be seen - the start of the increases matched the starting point of IMF programmes, and continued rising as the programme continued.

This meant at least a 16.6% increase in deaths across the 21 countries, they said.

Without the IMF loans, they suggested, rates would have fallen by up to 10%, meaning at least 100,000 extra deaths.

Countries which accepted IMF loans averaged an 8% fall in government spending, a 7% drop in the number of doctors per head of population, and a fall in a method of TB treatment called "directly observed therapy", which is recommended by the World Health Organisation.

David Stuckler, one of the study's authors, said that the IMF "had its priorities backwards".

"If we really want to create sustainable economic growth, we need first to ensure that we have taken care of people's most basic health needs."

'Fully supported'

The IMF disputed the findings, saying that it always supported public spending on "critical social needs" such as healthcare and education.

A spokesman said: "I suppose anyone can try finding a rationale for anything. This is an example of that.

"Efforts to attack tuberculosis in sub-Saharan Africa are fully supported by the IMF.

"Our extensive array of published analysis is clear evidence that we are very sensitive to the important role of healthcare and personal well being.

"We also have contacts and relations with international bodies who are expert in the area of healthcare and disease prevention and control.

"This doesn't seem to register with the authors."

Paul Sommerfeld, from the charity TB Alert, said the findings were "unsurprising".

"It has long been evident that the surge of TB in ex-USSR countries through the 90s was an unforeseen and unwelcome result of the end of communism - because of the vast drop in public spending, including on public health, of which IMF policies are a contributory part."

However, he said that an over-reliance on expensive "sanatoria" for TB patients was another reason for problems in Russia.

Tuberculosis (TB), chronic or acute bacterial infection that primarily attacks the lungs, but which may also affect the kidneys, bones, lymph nodes, and brain. The disease is caused by Mycobacterium tuberculosis, a rod-shaped bacterium. Symptoms of TB include coughing, chest pain, shortness of breath, loss of appetite, weight loss, fever, chills, and fatigue. Children and people with weakened immune systems are the most susceptible to TB. Half of all untreated TB cases are fatal.

This graph illustrates the number of new cases of tuberculosis in the United States since 1985. Many researchers attribute the sharp increase in the early 1990s to the spread of acquired immunodeficiency syndrome (AIDS). People with AIDS have weakened immune systems and are particularly susceptible to contagious diseases such as tuberculosis. Poorly supervised treatment of tuberculosis also led to an increase in drug-resistant strains of the bacteria that cause tuberculosis, furthering the spread of the disease. Renewed emphasis on control and prevention has brought the incidence of tuberculosis to record low levels.

In 1993 the World Health Organization (WHO) declared TB to be a global emergency, the first such designation ever made by that organization. According to WHO, one individual becomes infected with TB every second, and every year 8 million people contract the disease. Tuberculosis causes 2 million deaths a year. WHO predicts that between 2000 and 2020, nearly 1 billion people will become infected with the TB bacteria and 35 million people will die from the disease.